Use of Low Sensitivity Pregnancy Test for Self-assessment of Medical Abortion (m-Assist+)

University of Cape Town (UCT)

Status: Completed

Conditions: Completion of Medical Abortion

Treatments: Behavioral: Baseline verbal instruction on LSUPT

Study type: Interventional

Funder types: Other

Identifiers

NCT02231619

677/2013

Details and patient eligibility

About

The purpose of the study is to design a self-assessment package that could be the preferred option to a follow-up visit at the clinic by the majority of women having early medical abortion.

Enrollment: 525 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Already be signed up to do a medical abortion at this clinic
2. Be willing to come to all clinic appointments and be accessible by phone for 2 weeks after sign up for the study
3. Own a cellphone to which will be sent medical abortion-related information and messaging.

Exclusion criteria

1. Be doing a medical abortion due to failed natural miscarriage 2. Not have a working cellphone

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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525 participants in 2 patient groups

Demonstration of LSUPT at baseline

No Intervention group

Description:

This group conduct a LSUPT on their own urine sample at baseline with assistance from a fieldworker.

Baseline verbal instruction of LSUPT

Active Comparator group

Description:

Verbal instruction on how to do LSUPT at baseline

Treatment:

Behavioral: Baseline verbal instruction on LSUPT